The pharmaceutical and cosmetical industry, OEM manufacturers of medical devices and all industrial players in the healthcare sector are subject to strong regulations. But beyond the essential satisfaction of traceability requirements such as FDA 21CFR11, manufacturers in the sector must now take up the challenge of productivity, rapid training of personnel and maintaining cost of implementing IT solutions under control. The MES COOX solution was designed to meet these requirements.
Batch traceability and management of noncompliance have also become a part of the daily routine of the cosmetic industry, as the demands of consumers and legislation continue to rise.
Whether by means of GMPs (good manufacturing practices for drugs) or GLPs (good laboratory practices), manufacturers must be able to retrace the manufacturing history of every batch of drugs, and operators must be able to locate every batch, based on its destination. But that's not all. The pharmaceutical and cosmetic industries have also entered a period of strong competition, compelling them to handle their production and constraints with maximum efficiency.
Thus, beyond the essential satisfaction of traceability requirements such as FDA 21CFR11, industrialists in the sector must today take up the challenge of productivity, rapid training of personnel and cost of implementation. solutions mastered.
Optimal flexibility demanded by the market
Due to the nature of their products, drug and cosmetic manufacturers must be extremely flexible and be able to act or react quickly to new developments (new products released to market, new regulations, etc.).
The institution of flawless, increasingly-sophisticated identification technologies is a necessity today, so traditional barcodes have now been replaced by 2D barcodes and RFID systems...but is that enough?
A manufacturing management solution has now become indispensable, allowing industrialists to differentiate themselves. By controlling their production processes, improving their industrial processes, and obtaining real-time, systematic traceability of raw materials and processes, manufacturers can be responsible to market expectations and regulatory requirements, in accordance with standards for the sector
Graphic definition of manufacturing recipes, procedures and quality controls
With COOX, the industrial R&D department has full control over the definition of the process and its modifications through a simple and powerful graphic language. The processing of operations in parallel, the conditional execution of operations, the repetition of an operation or a sequence are, for example, easily expressed, allowing total autonomy and great responsiveness. Each modification of recipe’s properties are systematically traced with the author of the modification (audit trail).
Weighing management
Accurate weighing of the components of a formulation is a typical operation in the manufacture of drugs which must be performed, traced and checked carefully. COOX has a set of operations models of this type allowing the direct acquisition of information from a balance and the automated control of weighing tolerances. Going to the next operation will only be possible for correct weighing, possibly supplemented by other checks.
Help for operators
COOX allows the sequence of automatic, semi-automatic or manual operations. The operator is guided in the execution of his tasks by the display of the sequence of operations with their state of realization and by the integration of associated media: plans, photos, videos.
Electronic Batch Record - EBR
All the operations associated with the production of a batch are systematically traced electronically, with for each operation the equipment or workstation concerned, start and end dates of the operation, set parameters and actual parameters measured for each operation, operator’s identification and, if applicable, all the non-conformities or alerts that occurred during its execution. The batch records can be edited as PDF documents with a configurable level of detail (electric signature is part of it).
Electronic signature
In full compliance with international FDA 21CFR11 requirements, COOX MESbox allows the easy implementation at the level of an operation or group of operations of a verification process by an authorized manager. The identification of operators and verifiers is guaranteed by authentication by login and password or by biometric sensor.
Features of your MES software
With the COOX range, industrialists will enjoy quick returns on their investments and be ahead of the curve, over their competitors.
- Upward and downward product traceability (genealogy)
- Automated traceability and presentation of results in summary or detailed form
- Modeling of containers and material transfers
- Tree view of processes flows
- Tracking of shop inventories of raw materials and products
- FDA 21 CFR 11compliance
- Electronic signature
All of the features offered by the different modules, based on the COOX functional platform
